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DBV Technologies to Highlight New Clinical Data at ACAAI 2022

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DBV Technologies (DBVT) announced the presentation of new clinical data on Viaskin™ Peanut at the ACAAI Annual Scientific Meeting in Louisville, KY, from November 10-14, 2022. The data focuses on peanut-allergic toddlers aged 1-3 years, highlighting Viaskin Peanut's potential as a treatment option. Two abstracts have been accepted for presentation, including an oral presentation scheduled for November 12. The company aims to demonstrate the efficacy of its epicutaneous immunotherapy approach to peanut allergy prevention in young children, pending regulatory approval.

Positive
  • Presentation of new clinical data at ACAAI meeting.
  • Potential for Viaskin Peanut as a treatment option for toddlers.
  • Two abstracts accepted for oral and poster presentations.
Negative
  • Safety and efficacy of Viaskin Peanut not yet established by regulatory bodies.

Montrouge, France, November 9, 2022

DBV Technologies to Highlight New Clinical Data at ACAAI 2022

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new clinical data on the use of Viaskin™ Peanut (DBV712) 250 μg in peanut-allergic toddlers ages 1 to 3 years will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held November 10-14, 2022, in Louisville, KY. Two abstracts have been accepted, including one oral presentation and one poster presentation. These presentations will be available on DBV’s website, www.dbv-technologies.com, following the conclusion of the meeting for those who are unable to attend. DBV will also host a booth in the ACAAI Exhibit Hall from Friday, November 11, through Sunday, November 13.

This year’s meeting will also feature a “Product Theater” on the Evolution of the Prevention and Treatment of Peanut Allergy in Young Children. Professors Gideon Lack, M.D., and J. Andrew Bird, M.D., will engage in a lively discussion around how evidence from peanut allergy prevention and treatment studies in young children may impact current and future clinical practice. The Product Theater is scheduled for Saturday, November 12, from 9:35 a.m. to 10:00 a.m. EST in the Exhibit Hall, Upper Concourse.

DBV is the sole sponsor, via an independent educational grant, of the International Food Allergy Symposium, a full-day symposium that kicks off ACAAI. Leading experts from around the world will present various topics related to food allergy, including epidemiology, diagnostics, prevention and treatment. The symposium is scheduled for Thursday, November 10, from 8:00 a.m. to 6:00 p.m. EST. The Company is also sponsoring the 31st Annual FIT Bowl, a game show-type competition that tests the knowledge of participating teams from training programs around the country. The competition is set to be held on Saturday, November 12, from 5:30 p.m. to 7:30 p.m. EST in Commonwealth Ballroom Salons 1 & 2.

There is a significant unmet need that persists among toddlers suffering from peanut allergy. The additional data being presented at this year's ACAAI meeting highlight the potential for Viaskin Peanut as a treatment option for this young and vulnerable patient population if approved,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. We continue to work towards seeking approval to bring this novel treatment option to market as expeditiously as possible.”

Viaskin Peanut is the Company’s lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. An investigational, non-invasive, once-daily epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to re-educate the immune system. The safety and efficacy of Viaskin Peanut have not yet been established by the U.S. Food and Drug Administration or the European Medicines Agency. Viaskin is DBV’s proprietary approach to epicutaneous immunotherapy (EPIT™), a method of delivering biologically active compounds to the immune system through the skin.

DBV Abstracts:

Oral Presentation

“EPITOPE Study Results: Phase 3, Randomized, Double-blind, Placebo-controlled Study of Epicutaneous Immunotherapy in Peanut-allergic Toddlers” will be presented by Matthew Greenhawt, M.D., M.Sc., MBA, FACAAI, Children’s Hospital Colorado, Aurora, CO.

  • Presentation ID: D019
  • Session Title: Distinguished Industry Oral Abstracts - Session B
  • Presentation Date: Saturday, November 12
  • Presentation Time: 4:30 p.m. – 5:30 p.m. EST
  • Presentation Location: Room M104 - M107

Poster Presentation

Reduction in Reaction Severity Following 12 Months of Epicutaneous Immunotherapy with Peanut Patch in Toddlers will be presented by Terri Brown-Whitehorn, M.D., Children’s Hospital of Philadelphia, Philadelphia, PA.

  • Presentation ID: P183
  • Session Title: ePoster – Meet the Author
  • Presentation Date: Friday, November 11
  • Presentation Time: 3:00 p.m. EST
  • Presentation Location: Exhibit Hall (Upper Concourse), Monitor 16

About DBV Technologies
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin™ Peanut as a treatment for peanut-allergic children and the potential benefits of EPIT™. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties and may be impacted by market conditions as well as other risks and uncertainties set forth in DBV Technologies’ regulatory filings with the Autorité des Marchés Financiers (“AMF”), DBV Technologies’ filings and reports with the U.S. Securities and Exchange Commission (“SEC”), and future filings and reports made with the AMF and SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

Investor Contact
Anne Pollak
DBV Technologies
+1 857-529-2363
anne.pollak@dbv-technologies.com

Media Contact
Angela Marcucci
DBV Technologies
+1 646-842-2393
angela.marcucci@dbv-technologies.com 

Viaskin and EPIT are trademarks of DBV Technologies.

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FAQ

What new data will DBV Technologies present at the ACAAI Annual Meeting?

DBV Technologies will present new clinical data regarding Viaskin Peanut for peanut-allergic toddlers aged 1-3 years, including results from the EPITOPE study.

When is the DBV Technologies' oral presentation scheduled during ACAAI?

The oral presentation is scheduled for November 12, 2022, from 4:30 p.m. to 5:30 p.m. EST.

What is the purpose of the Viaskin Peanut patch?

Viaskin Peanut is designed to reduce the risk of allergic reactions to peanuts via epicutaneous immunotherapy.

What are the implications of the presented data for DBVT shareholders?

The presented data could influence regulatory approval processes and market potential for Viaskin Peanut, impacting DBVT's stock performance.

DBV Technologies S.A.

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Biotechnology
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